Technical Data Monograph
V-PRO® maX
Low Temperature Sterilization System

Table of Contents
1. Introduction  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3
2. Principle of Operation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  4
3. Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  7
4. Performance Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  8
5. Materials Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  17
6. Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19
7. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  192

1

Introduction
This Technical Data Monograph illustrates the principles of operation and demonstrates the safety and efficacy of the V-PRO maX
Low Temperature Sterilization System. The summary test data for microbicidal efficacy, material compatibility, and biocompatibility
testing performed on the V-PRO maX Sterilizer are included.
The V-PRO maX Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer
intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare
facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure andlow temperature and are suitable for processing medical devices sensitive to heat and moisture.
The V-PRO maX Low Temperature Sterilization System’s Lumen Cycle can sterilize: (a)• Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)◦◦ single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length◦◦ dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length◦◦ triple channeled devices with stainless steel lumens that are▪▪ ≥1.2 mm ID and ≤ 275 mm in length▪▪ ≥1.8 mm ID and ≤ 310 mm in length
			or▪▪ ≥2.8 mm ID and ≤ 317 mm in length(a) The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) lumens perload. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies
were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
The V-PRO maX Low Temperature Sterilization System’s Non Lumen Cycle can sterilize: (b)• Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible
endoscopes and non-lumened instruments with stainless steel or titanium diffusion-restricted areas such as the hinged portion offorceps or scissors.
(b) The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs.
The V-PRO maX Low Temperature Sterilization System’s Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:
1. Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load. (c). The flexible
endoscopes may contain either:◦◦ a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length◦◦ or two lumens with:▪▪ one lumen that is ≥ 1 mm ID and ≤ 990 mm in length▪▪ and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length(c) The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and lightcord (if not integral to endoscope).
2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including
instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. (d)The flexible endoscope can contain either:◦◦ a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length◦◦ or two lumens with:▪▪ one lumen that is ≥ 1 mm ID and ≤ 990 mm in length▪▪ and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length(d) The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral toendoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

3

Single-use, medical grade polyethylene (PE) and Teflon®1 (polytetrafluoroethylene) tubing with internal diameter ≥ 1 mm andlength ≤ 4 meters may be sterilized in the Flexible Cycle. Up to 26 pieces of tubing with no additional load may be sterilized.2
The principle features of the V-PRO maX Low Temperature Sterilization System include:• Large, easy to use touch screen control panel that is used to initiate and monitor the validated sterilization cycles.
• Proprietary hydrogen peroxide based sterilant which is provided in a multi-cycle container.
• Process monitoring and cycle documentation.
• Automatic load aeration.
• System designed for ease of use and maintenance.
• Easy installation – no utilities other than electricity required; no special venting required.
• Specially designed conditioning phase that aids in removal of residual moisture. All loads should be thoroughly dried before packaging and placing into the sterilizer.
The V-PRO maX Low Temperature Sterilization System consists of several components. These components include:• The V-PRO maX Sterilizer• VAPROX HC Sterilant• Self-Contained Biological Indicator• Biological Indicator Test Packs• Chemical Indicator Tape
• External Process Indicators and Chemical Indicator Strips• Record Cards and Record Keeping Systems• V-PRO® Sterilization Trays, Instrument Organizers, and Silicone Mats
• Vis-U-All™ Low Temperature Tyvek®3 Pouches and Tubings
Teflon is a registered trademark of The Chemours Company, LLC.
Tubing claims have not been reviewed by the Food and Drug Administration.
3. Tyvek is a registered trademark of E.I. du Pont de Nemours and Company (DuPont).
1.
2.

2

V-PRO maX Low Temperature Sterilization System:
Principle of Operation

The V-PRO maX Low Temperature Sterilization System uses vaporized hydrogen peroxide or VHP to sterilize medical instruments.
Prior to sterilization, cleaned and dried instruments are packaged in wrapped trays, rigid containers or Tyvek pouches that are specifically designed for use with the V-PRO maX Sterilizer. The packaged instruments are placed on the Sterilizer’s two shelves andthe sterilizer door is shut. The V-PRO maX Sterilizer's Non Lumen, Lumen or Flexible Cycle is selected to initiate the sterilization
process.

4Non Lumen Cycle
The approximately 28-minute Non Lumen Cycle is used to sterilize instruments without lumens (i.e. surface sterilization) such asdefibrillator paddles, cables, cords, non-lumened rigid endoscopes (telescopes), batteries and cameras. The Non Lumen Cycle canbe used to sterilize instruments with stainless steel or titanium mated surfaces such as the hinged portion of forceps or scissors. If theload contains a stainless steel lumened instrument, the Lumen Cycle4 must be selected. If the load contains a flexible endoscope withlumens the Flexible cycle5 must be selected. If the load contains a mated surface other than stainless steel or titanium, the Lumen
Cycle or Flexible cycle must be selected. The prepared and packaged load is processed through a short moisture check phase during
which the chamber pressure is reduced to 1 Torr (or 0.13 kPa) and the moisture content of the load is verified to be acceptable. If the
moisture content is not acceptable, a short conditioning phase is initiated during which the chamber is evacuated to less than 1 Torr
(0.13 kPa) to aid in removal of excess moisture. After the optional conditioning phase, the moisture content of the load is verified tobe acceptable. The pressure in the sterilizer chamber is then reduced to 1 Torr (0.13 kPa) in preparation for injection of the VHP. The
sterilizer automatically vaporizes the correct amount of liquid hydrogen peroxide from the multiple-cycle VAPROX HC Sterilant
cup. After a two-minute hold segment, filtered air enters the sterilization chamber, increasing the chamber pressure to 500 Torr (or66.7 kPa). After an additional 1 minute hold segment, the chamber pressure is again reduced to 1 Torr (0.13 kPa) in preparation for
the next injection of VHP. VHP is injected four times during each sterilization cycle. Each injection is called a sterilization pulse.
After completion of the last VHP injection hold segment, the load is automatically aerated in the sterilizer. The chamber VHP is
exhausted through a catalytic converter that decomposes the VHP to water and oxygen. No special venting is required for operationof V-PRO maX Sterilizer. At completion of the sterilization cycle, the load is removed and can be immediately used or stored prior touse. The cycle is presented graphically in Figure 1.

Figure 1. Pressure Graph of the V-PRO maX Sterilizer's Non Lumen Cycle
1000.0

Moisture
Check

Sterilize

AeratePressure (Torr)

100.0

10.0

1.0
Pulse 1

Pulse 2

Pulse 3

Pulse 40.1

Time (min)5Lumen Cycle

The approximately 55-minute cycle is used to sterilize instruments with stainless steel lumens4 and mated surfaces. The prepared andpackaged load is processed through a short conditioning phase during which the chamber is evacuated to less than 1 Torr (or 0.13kPa). After the conditioning phase, the moisture content of the load is verified to be acceptable. The pressure in the sterilizer chamberis then reduced to 0.4 Torr (or 0.05 kPa) in preparation for injection of VHP. The sterilizer automatically vaporizes the correct amountof liquid hydrogen peroxide from the multiple-cycle VAPROX HC Sterilant cup. After a six-minute hold segment, filtered air enters
the sterilization chamber, increasing the chamber pressure to 500 Torr (or 66.7 kPa). After an additional 2-minute hold segment, thechamber pressure is again reduced to 0.4 Torr (or 0.05 kPa) in preparation for the next injection of VHP. VHP is injected four times
during each sterilization cycle. Each injection is called a sterilization pulse. After completion of the last VHP injection hold segment,
the load is automatically aerated in the sterilizer. The chamber VHP is exhausted through a catalytic converter that decomposes the
VHP to water and oxygen. No special venting is required for operation of the V-PRO maX Sterilizer. At completion of the sterilization
cycle, the load is removed and can be immediately used or stored prior to use. The cycle is presented graphically in Figure 2.

Figure 2. Pressure Graph of the V-PRO maX Sterilizer's Lumen Cycle
Sterilize

Condition

Aerate1000.0Pressure (Torr)

100.0

10.0

1.0

Pulse 1

Pulse 2

Pulse 3

Pulse 4

0.1

0

2

4

6

8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56

Time (min)4.
5.

Only stainless steel lumen configurations identified on page 3 can be sterilized in the Lumen Cycle.
Only flexible surgical endoscopes or bronchoscopes with dimensions identified on page 3 can be sterilized using the Flexible Cycle.

6Flexible Cycle
The approximately 35-minute Flexible Cycle is used to sterilize surgical flexible endoscopes (such as those used in ENT, Urology andSurgical Care) and bronchoscopes with lumens and other non-lumened devices (i.e. surface sterilization) such as defibrillator paddles,
cables, cords, non-lumened rigid endoscopes (telescopes), batteries and cameras. The Flexible Cycle can be used to sterilize either
two single or dual channel flexible endoscopes in a cycle or a single flexible endoscope and non-lumened devices, including matedsurfaces [up to a total of 24 lbs (10.9 kg) per cycle].5 Stainless steel lumened instruments4 cannot be processed in the Flexible Cycle.
The prepared and packaged load is processed through a short moisture check phase during which the chamber pressure is reduced to
0.4 Torr (or 0.05 kPa) and the moisture content of the load is verified to be acceptable. If the moisture content is not acceptable, a shortconditioning phase is initiated during which the chamber is evacuated to less than 0.4 Torr (or 0.05 kPa) to aid in removal of excess
moisture. After the optional conditioning phase, the moisture content of the load is verified to be acceptable. The pressure in the sterilizer chamber is then reduced to 0.4 Torr (or 0.05 kPa) in preparation for injection of the VHP. The sterilizer automatically vaporizes
the correct amount of liquid hydrogen peroxide from the multiple-cycle VAPROX HC Sterilant cup. After a two-minute hold segment,
filtered air enters the sterilization chamber, increasing the chamber pressure to 500 Torr (or 66.7 kPa). After an additional 1-minutehold segment, the chamber pressure is again reduced to 0.4 Torr (or 0.05 kPa) in preparation for the next injection of VHP. VHP is
injected four times during each sterilization cycle. Each injection is called a sterilization pulse. After completion of the last VHP
injection hold segment, the load is automatically aerated in the sterilizer. The chamber VHP is exhausted through a catalytic converter
that decomposes the VHP to water and oxygen. No special venting is required for operation of V-PRO maX Sterilizer. At completionof the sterilization cycle, the load is removed and can be immediately used or stored prior to use. The cycle is presented graphically in
Figure 3.
Figure 3. Pressure Graph of V-PRO maX Sterilizer's Flexible Cycle
Sterilize

Condition

Aerate1000.0Pressure (Torr)

100.0

10.0

1.0

Pulse 1

Pulse 2

Pulse 3

Pulse 4

0.1

3

0

2

4

6

8

10

12

14

16

18

20

22

24

26

28

30

32

34

Time (min)Consumables

Sterilant

VAPROX HC Sterilant is a proprietary, 59% liquid hydrogen peroxide sterilant that is contained in a multi-cycle cup. The sealed cup
is placed into the sterilizer’s cup interface and the door is closed. The sterilizer confirms that the sterilant cup is within its expiration
date prior to automatically opening the sterilant cup. The sterilant cup has been engineered for safe and easy handling.

7

Sterility Assurance and Sterile Packaging
The VERIFY® biological and chemical indicator products and Vis-U-All Low Temperature Sterilization Pouches have been designed
and validated for use with the V-PRO maX Low Temperature Sterilization processes. Each product is designed to meet applicable
International Standards. Only use products that have been validated for the V-PRO maX Low Temperature Sterilization System.
Failure to do so may result in a non-sterile device or ineffective monitoring of the load.

Equipment Control
VERIFY Equipment Control Products monitor the critical performance characteristics of the sterilization process. As part of any
Sterility Assurance Program, these products confirm that the equipment used is functioning correctly. Biological indicators such as the
VERIFY® V24 Self-Contained Biological Indicator offer a fast means of weekly or daily microbial monitoring while test packs suchas the VERIFY® V24 Challenge Pack provide assurance following installation, relocation or major repair.

Load Control
The V-PRO maX Low Temperature Sterilization System provides cycle printouts for verification of critical performance parameters. A
place is provided for the cycle reviewer’s initials or signature. Biological indicators such as the VERIFY V24 Self Contained Biological Indicator may also be used to monitor and release loads.

Pack Control
Chemical Indicator strips such as the VERIFY Vaporized VH2O2 Process Indicator confirm that sterilant is able to penetrate thepacks to be sterilized. Each indicator provides the last check prior to use of the device. The indicator strips are designed to fit insterilization pouches or trays.

Process Control and Record Keeping
A variety of external process indicators, record cards, record envelopes and logs are available for use with the V-PRO maX Low Temperature Sterilization System. These items are used to prevent the mix up of sterilized items by labeling the packs prior to processing
and to ensure complete documentation of sterilization processes.

4

Performance Evaluation

Microbicidal Efficacy Testing
STERIS Corporation conducted tests to validate the microbicidal efficacy of the V-PRO maX Low Temperature Sterilization System’s
three sterilization cycles. The following summarizes the test data demonstrating that the V-PRO maX Sterilizer cycles and VAPROXHC Sterilant are effective.

Sterility Assurance Level (SAL) Testing
An SAL of 10-6 was established for the V-PRO maX Sterilization System by performing ½ cycle testing using inoculated test articles
to simulate medical instruments under worst case sterilization conditions.

Worst Case Test Conditions - Most Resistant Organism
STERIS conducted vaporized hydrogen peroxide (VHP) resistance testing under greatly reduced exposure conditions with a variety oforganisms (Table 1) and bacterial endospores (Table 2) to identify the most resistant organism to VHP.

8

Table 1. Microbial Resistance to VHP*
Test Organism

Log of Recovered Population at Exposure Time (min)
0

1

2

5

Geobacillus stearothermophilus spores, ATCC 7953

5.8

4.5

4.6

3.8

Mycobacterium terrae, ATCC 15755

5.9

5.2

4.2

†

Staphylococcus aureus, ATCC 6538

5.0

4.4

2.1

†

Pseudomonas aeruginosa, ATCC 15442

5.7

3.2

0.8

†

Salmonella choleraesuis, ATCC 10708

5.3

3.4

0.8

†

Aspergillus niger spores, ATCC 6275

5.1

2.6

†

†

Klebsiella pneumoniae, ATCC 4352

4.2

3.2

†

†

Trichophyton mentagrophytes spores, ATCC 18748

5.4

2.9

†

†

* Exposure to 1.8 g/min VHP in a 0.6m Isolator†† No organism recovered
3

Table 2. Bacterial Spore D-Values*
Test Organism

D-Value (seconds)

Geobacillus stearothermophilus spores, ATCC 7953

42.3

Bacillus subtilis spores, ATCC 19659

18.7

Clostridium sporogenes spores, ATCC 3584

15.6

Bacillus circulans spores, ATCC 4513

14.4

Bacillus cereus spores, ATCC 12826

9.9* Exposure to 1.8 g/min VHP in a 0.6m3 Isolator

Conclusion
Geobacillus stearothermophilus endospores are the most resistant organism and therefore were used to validate the V-PRO maX Low
Temperature Sterilization System’s SAL and microbicidal efficacy.

Sterilizer Load
The SAL microbial tests were conducted in the presence of a validation load appropriate for the cycle. Additionally, in the Flexible
Cycle, single use PE and Teflon tubing were packaged in either double Tyvek pouches or double wrapped trays. Up to 26 pieces oftubing were processed at one time, with no additional load.2

V-PRO maX Sterilization System ½ Cycle
For the SAL studies, ½ cycle evaluation was conducted. The ½ cycle consisted of a moisture check/conditioning phase, 2 sterilization
pulses, and an aeration phase. This exposes the test articles to ½ the amount of vaporized hydrogen peroxide (2 sterilization pulses vs.
4 for a full cycle) for ½ of the total sterilant exposure time.
Medical instrument material coupons (Table 3 and 7), mated configuration medical instrument coupons (Table 4), stainless steel
lumens (Table 5), Teflon lumens (Table 6 and 7) and PE and Teflon tubing (Table 8) were challenged with 106 Geobacillus stearothermophilus spores and dried. The test articles were placed within the validation load and exposed to a V-PRO maX Sterilizer's Lumen½ Cycle, Non Lumen ½ Cycle or Flexible ½ Cycle. After exposure, the test articles were cultured and the number sterile versus
number tested determined. All of the medical instrument materials, mated configuration materials, lumens and tubing were sterile after
exposure to ½ cycles of the V-PRO maX Sterilizer (Tables 3-8).
Due to the similarities between the Non Lumen and the Flexible Cycles, device materials evaluations conducted in the Non Lumen
Cycle support the microbicidal efficacy of the Flexible Cycle.

9Table 3. ½ Cycle Microbicidal Efficacy Evaluation – Medical Instrument Materials
Medical Instrument Material# Sterile/# Tested
Non Lumen Cycle*

Lumen Cycle

Aluminum

15/15

20/20

Brass

15/15

20/20

Delrin

15/15

20/20

Ethyl vinyl acetate (EVA)

15/15

20/20

Glass
KratonNeoprene
Noryl (Polyphenylene Oxide)
Nylon
Polyether Ether Ketone (PEEK)Polymethyl methacrylate (PMMA)
Polycarbonate
Polyethylene
Polypropylene
Polystyrene
Polyvinyl chloride (PVC)
Polyurethane
Radel
Silicone
Stainless Steel
TeflonTitanium
Ultem (Polyetherimide)

15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15
15/15

20/20
20/20
20/20
20/20
20/20
**
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20
20/20

* Tests conducted in the Non Lumen Cycle qualify materials for sterilization in the Flexible Cycle.
** Tests conducted in the Non Lumen Cycle qualify materials for sterilization in the Lumen Cycle.

Table 4. ½ Cycle Microbicidal Efficacy Evaluation - Mated Instrument Materials
Material

Coupon Pairs Sterile/Pairs Tested
Non Lumen Cycle

Flexible Cycle**

Stainless Steel

6/6

***

Titanium

6/6***

Delrin
Ultem
Radel

6/6
N/A*

Noryl
* N/A = Not Applicable. The Non Lumen Cycle is only intended to sterilize stainless steel or titanium mated surfaces.
** Tests conducted in the Flexible Cycle qualify materials for sterilization in the Lumen Cycle.
*** Tests conducted in the Non Lumen Cycle qualify materials for sterilization in the Flexible and Lumen Cycles

10

6/6
6/6
6/6

Table 5. ½ Cycle Microbicidal Efficacy Evaluation for theV-PRO maX Sterilizer's Lumen
Cycle with Stainless Steel Lumens# Sterile/# Tested

Medical Instrument Material

Lumen Size
(ID** x Length mm)

Trial 1

Trial 2

Trial 3Single0.77 x 500

12/12

12/12

12/12

0.77 x 527

1/1

1/1

1/1

1.17 x 500

1/1

1/1

1/1

1.2 x 275

1/1

1/1

1/1

1.2 x 275

1/1

1/1

1/1

1.8 x 310

1/1

1/1

1/1

(2x1.5)* x 285

1/1

1/1

1/1

1.8 x 300

1/1

1/1

1/1

2.8 x 317

1/1

1/1

1/1

Dual

TripleTriple* Oval channel** ID = Internal Diameter

Table 6. ½ Cycle Microbicidal Efficacy
Evaluation for the V-PRO maX Sterilizer's
Flexible Cycle with Flexible Endoscope Load

Table 7. ½ Cycle Microbicidal Efficacy
Evaluation for the V-PRO maX Sterilizer's
Flexible Cycle with Mixed Load

Lumen Size (ID x Length mm)# Lumens Sterile/# Tested

Test Article# Sterile/# Tested

1 x 1050

30/30

1 mm ID x 1050 mm
Length Lumens

15/15

Worst Case Material Coupons

9/9

Table 8. ½ Cycle Microbicidal Efficacy Evaluation for the V-PRO maX
Sterilizer's Flexible Cycle with Polyethylene and Teflon Tubing
Worst case Test Article

No. of Test Articles Sterile/No. Tested

Double Pouched Teflon Tubing

3/3

Double Pouched Polyethylene Tubing

3/3

Double Wrapped Teflon Tubing

3/3

Double Wrapped Polyethylene Tubing

3/3

Conclusion
All of the device materials, mated device materials and lumens challenged with 106 Geobacillus stearothermophilus spores weresterile after exposure to either a Lumen ½ Cycle, Non Lumen ½ Cycle, or Flexible ½ Cycle, as applicable, thereby establishing a SALof 10-6 for the V-PRO maX Low Temperature Sterilization System.

Modified Total End Point Kill (VHP Dose Evaluation)
Using the inoculated steel lumen test articles described in Table 5 that had been placed within the validation load, various amountsof hydrogen peroxide were introduced into the chamber under Lumen ½ Cycle conditions. The number of sterile test articles versus
number tested was determined. All lumens were sterile at the normal sterilant concentration of 8.6 mg/L VHP as well as at the lower
concentration of 6.0 mg/L VHP (Table 9).

11

Table 9. VHP Dose Evaluation of the V-PRO maX Sterilizer's
Lumen Cycle
VHP Concentration* (mg/L)# Sterile Lumens /# Tested

0.5

0/60

2.5

50/60

5.0

57/60

6.0

60/60

8.6

60/60

* Calculated Chamber Concentration

A similar experiment was conducted in the V-PRO maX Sterilizer's Non Lumen Cycle. Tests established the worst case challengematerial to the V-PRO maX Sterilizer's Non Lumen Cycle. The inoculated and dried worst case challenge material coupon test articles
were placed within the validation load. Various amounts of hydrogen peroxide were introduced into the chamber under Non Lumen½ Cycle conditions. The number of sterile test articles versus number tested was determined. All worst case material coupons weresterile at the normal sterilant concentration of 8.6 mg/L VHP as well as at the lower concentration of 6.0 mg/L VHP (Table 10).

Table 10. VHP Dose Evaluation of the V-PRO maX Sterilizer's Non Lumen Cycle
VHP Concentration* (mg/L)# Sterile Coupons /# Tested

2.5

9/18

5.0

16/18

6.0

18/18

8.6

18/18

* Calculated Chamber Concentration

The two load configurations for the V-PRO maX Sterilizer's Flexible Cycle, 2 flexible endoscopes (Flexible endoscope load) and 1
flexible endoscope with non-lumened load (≥ 24.0 lbs, Mixed Device Load), were exposed to varying concentrations of VHP and thenumber of sterile articles versus number tested was determined. All lumens were sterile at the normal sterilant concentration of 8.6
mg/L VHP as well as at the lower concentration of 6.0 mg/L VHP (Tables 11 and 12).

Table 11. VHP Dose Evaluation of the V-PRO maX Sterilizer's Flexible Cycle with Flexible
Endoscope Load
VHP Concentration* (mg/L)# Sterile Lumens /# Tested

0.5

0/30

2.5

2/30

5.0

29/30

6.0

30/30

8.6

30/30

* Calculated Chamber Concentration

12

Table 12. VHP Dose Evaluation of the V-PRO maX Sterilizer's Flexible Cycle with
Mixed Device Load
VHP Concentration* (mg/L)
0.5
2.5
5.0
6.0
8.6

# Sterile Lumens/ #Tested
0/15
0/15
10/15
15/15
15/15

# Sterile Coupons/ # Tested
0/9
7/9
9/9
9/9
9/9

* Calculated Chamber Concentration

Conclusion
The V-PRO maX Sterilizer's Non Lumen, Lumen and Flexible Cycles effectively kill 106 G. stearothermophilus spores, the mostresistant organism, in a half cycle evaluation at concentrations below the normal minimum injected concentration of 8.6 mg/L VHP.

AOAC Sporicidal Test Evaluation
AOAC sporicidal carrier testing was performed in situ to demonstrate the sporicidal efficacy of the V-PRO maX Low Temperature
Sterilization System. The test uses two types of test organisms (spores of Clostridium and Bacillus), in the presence of test soil, on
two different porous surface carrier types (penicylinders and sutures). Testing was performed as defined in the Official Methods ofAnalysis of the AOAC International Association of Official Analytical Chemists, 17th Edition, 2000/2006, AOAC Official Method
966.04, “Sporicidal Activity of Disinfectants.” It is required that a combination of at least 720 carriers are tested and all are required
to demonstrate the absence of growth following exposure and incubation. All 720 carriers were confirmed to be sterile following
exposure to either the V-PRO maX Sterilizer's Non Lumen Cycle using three separate lots of VAPROX HC Sterilant (Table 13).
Sporicidal testing conducted in the V-PRO maX Sterilizer's Non Lumen Cycle verifies efficacy in the V-PRO maX Sterilizer's Flexible
Cycle. The same evaluation conducted in the Lumen Cycle yielded all sterile results.

Table 13. AOAC Sporicidal Carrier Evaluation in the V-PRO maX Sterilizer's
Lumen or Non Lumen Cycle*#Sterile/#Tested
21 Days

Carrier

24 Days (post heat-shock)

1° Tube2° Tube1° Tube2° TubeBacillus subtilis penicylinder

180/180

180/180

180/180

180/180

Bacillus subtilis suture loop

180/180

180/180

180/180

180/180

Clostridium sporogenes penicylinder

180/180

180/180

180/180

180/180

Clostridium sporogenes suture loop

180/180

180/180

180/180

180/180

Total

720/720720/720720/720720/720* Tests conducted in the Non Lumen Cycle also qualify the Flexible Cycle

Conclusion
The V-PRO maX Low Temperature Sterilization System effectively inactivates bacterial endospores when evaluated by the AOAC
carrier method. VAPROX HC Sterilant is sporicidal.

Medical Instrument Testing
STERIS Corporation conducted tests to validate the V-PRO maX Low Temperature Sterilization Systems’ ability to sterilize medical
instruments. The following summarizes the test data demonstrating that the V-PRO maX Sterilizer and VAPROX HC Sterilant are
effective under simulated worst case use and clinical use conditions.

Simulated Use Evaluation
Worst case medical instruments with regard to size and features that are challenging to sterilize, were inoculated with 106 G. stearothermophilus spores with 5% fetal bovine serum and 300 ppm AOAC hard water. The inoculated and dried medical instruments
were processed through V-PRO maX Sterilizer's Lumen, Non Lumen or Flexible Cycles. After exposure, the medical instrument sites
were sampled and evaluated for growth of the test organism. The number of sterile devices versus the number of devices tested wasdetermined (Tables 14, 15, 16, and 17). All devices were sterile under worst case simulated use conditions.

13

Table 14. V-PRO maX Sterilizer's Non Lumen Cycle Simulated Use Evaluation
Medical Instrument

Inoculation Site

# Sterile / # Tested

Cavity Clip

Surface

3/3

Colorectal Intestinal Dilator

Surface

3/3

Slide for Cannula Tubing

Surface

3/3

Defibrillator

Spoon

3/3

High Frequency Cord

Surface

3/3Light Cable

Cable

3/3

Ocular Lens

Lens

3/3

Electrosurgical Forceps

Surface

3/3

Telescope

Ocular Surface

3/3

Surgical Scissors

Hinge (Mated Surface)

3/3

CameraLens

3/3

Battery

Housing

3/3

Non Lumened Flexible Endoscope

Insertion Tube

3/3

Table 15. V-PRO maX Sterilizer's Lumen Cycle Simulated Use Evaluation
Medical Instrument

Inoculation Site

# Sterile / # Tested

Surgical Scissors
Towel Forceps
Fixation Hooks/Retractor
Light Cable
CameraPacemaker Cables
Batteries

Hinge (Mated Surface)
Clamp
Tines
Cord
Lens
Lead Connector
Housing
Contact area with organizer
OcularHandleSpoons back
0.77 ID* x 527 mm lumen
1.17 ID x 500 mm length lumens

3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3
3/3

1.2 ID x 275 mm length lumen

3/3

2.8 ID x 317 mm length lumen

3/3

Cystoscope
Defibrillator Paddles
Ureteroscope(dual channel)
Hysteroscope(triple channel)
Sheath (triple channel)* ID = Internal Diameter14

Table 16. V-PRO maX Sterilizer's Flexible Cycle Simulated Use Evaluation with
Flexible Endoscope Load
Medical Instrument

Inoculation Site

# Sterile / # Tested

Flexible Epiduroscope

1 mm ID* x 1075 mm length lumen
1.5 mm ID x 700 mm length
2 mm ID x 730 mm length lumens

3/3
3/3
3/3

Flexible Dual Channel
Bronchoscope* ID = Internal Diameter

Table 17. V-PRO maX Sterilizer's Flexible Cycle Simulated Use Evaluation with
Mixed Device Load
Medical Instrument

Inoculation Site

# Sterile / # Tested

Flexible Epiduroscope

1 mm ID* x 1075 mm length lumen

3/3

Flexible Dual Channel Ureterorenoscope

1 mm ID x 990 mm length and
1 mm ID x 850 mm length lumens

3/3

Cavity Clip

Surface

3/3

Colorectal Intestinal Dilator

Surface3/3

Flexible Nasopharyngoscope

Surface

3/3

Scissors

Hinge (Mated Surface)

3/3* ID = Internal Diameter

Conclusion
The V-PRO maX Low Temperature Sterilization Systems utilizing VAPROX HC Sterilant reproducibly sterilizes challenging medical
instruments inoculated with high levels of the most resistant organism, G. stearothermophilus spores.

Clinical Use Evaluation
The V-PRO maX Low Temperature Sterilization System sterilization cycles were evaluated in a clinical setting with medical instruments that had been used in clinical procedures. The instruments were cleaned, dried, packaged and exposed to either the Non Lumen,
Lumen or Flexible Cycles. After exposure, selected medical instrument sites were sampled and evaluated for growth of organisms.
The number of sterile instrument sites versus the number of instrument sites tested was determined. All instruments were sterile underclinical use conditions (Tables 18, 19, 20 and 21).

Table 18. V-PRO maX Sterilizer's Non Lumen Cycle Clinical Use Evaluation
Medical Instrument

Selected Site

# Sterile / # Tested

Surgical Scissors

Hinge

3/3

Colorectal Intestinal Dilators

Surface

3/3Syringe Plunger

Tip

3/3

Defibrillator Paddle

Spoon

3/3

Light Cord

Cord

3/3

Bipolar Cable

Cable

3/3

Electrosurgical Forceps

Surface

3/3

CameraLens

3/3

Batteries

Housing

3/3

Telescope

Ocular Surface

3/3

15

Table 19. V-PRO maX Sterilizer's Lumen Cycle Clinical Use Evaluation
Medical Instrument

Selected Site

# Sterile / # Tested

Surgical Scissors

Hinge

3/3

Towel Forceps

Clamp

3/3

Skin/Fixation Hooks/Retractor

Tines

3/3

Handle3/3

Spoon back

3/3

Light Cable

Cord

3/3

CameraLens

3/3

Pacemaker Cables

Lead Connector

3/3

Batteries

Housing

3/3

Contact area with organizer

3/3

Ocular

3/3

Defibrillator Paddles

Telescope

Ureteroscope (dual channel)

Hysteroscope (triple channel)orSheath (triple channel)

0.77 mm ID** x 510 mm lumen,
1.17 mm ID x 500 mm length lumens
or0.85 mm ID x 520 mm lumen,
1.4 mm ID x 520 mm length lumens
1.2 mm ID x 275 mm lumen,
1.2 mm ID x 275 mm lumen,
1.8 mm ID x 310 mm length lumens
or
2.8 mm ID x 317 mm lumen
1.8 mm ID x 300 mm lumen(2 x1.5)* mm ID x 285 length mm lumens

6/6

9/9

* crescent shaped lumen** ID= Internal Diameter

Table 20. V-PRO maX Sterilizer's Flexible Cycle Clinical Use Evaluation with
Flexible Endoscope Load
Medical Instrument

Selected Site

# Sterile / # Tested

Flexible Laryngoscope

1.5 mm ID* x 768 mm length lumen

3/3

Flexible Dual Channel
Bronchoscope

1.5 mm ID x 700 mm length and
2.0 mm ID x 730 mm length lumen

3/3
3/3

* ID = Internal Diameter

Table 21. V-PRO maX Sterilizer's Flexible Cycle Clinical Use Evaluation with
Mixed Device Load
Medical Instrument

Selected Site

# Sterile / # Tested
3/3

Flexible Endoscopes

1.5 mm ID* x 768 mm length or
1.0 mm ID x 825 mm length lumen
Insertion Tube Surface

3/3

Colorectal Intestinal Dilator

Surface

3/3

Surgical Scissors

Hinge

3/3

Syringe Plunger

Tip

3/3

Flexible Dual Channel
Ureterorenoscope

1 mm ID x 990 mm length and
1 mm ID x 850 mm length lumens

3/3* ID = Internal Diameter

16

3/3

3/3

Conclusion
The V-PRO maX Sterilizer's Non Lumen, Lumen and Flexible Cycles utilizing VAPROX HC Sterilant reproducibly sterilize clinicallyused medical instruments.

Overall Conclusions of Microbicidal Efficacy Evaluations
STERIS Corporation has validated the microbicidal efficacy of the V-PRO maX Low Temperature Sterilization System:• An SAL of 10-6 has been established through ½ cycle testing and modified total end point kill analysis.
• The system passed the AOAC Sporicidal Test.
• Simulated and Clinical use testing has shown that instruments are sterile when processed in the V-PRO maX Sterilizer utilizing

5

VAPROX HC Sterilant.

Materials Compatibility

The V-PRO maX Sterilization process is compatible with a wide range of medical instruments and materials. STERIS Corporation
performed medical instrument materials compatibility evaluations to ensure that the V-PRO maX Low Temperature Sterilization
System is safe for medical instruments. Representative medical instruments composed of a variety of materials were subjected to fifty
Lumen Cycles (worst case, longest sterilant exposure in the V-PRO maX Sterilizer) with functional evaluations performed before andafter the tests. Table 22 lists the materials and type of instruments evaluated for material compatibility.

Table 22. Material Compatibility
Materials
Aluminum

Instrument Evaluated

Cosmetic Change

Telescope

None

Wide Field Vitrectomy Lens

Loss of black color

Functionality
Pass

Resectoscope Working Element
Brass

High Frequency Cord
Defibrillator

None

Pass

None

Pass

Slight yellowing

Pass

None

Pass

None

Pass

Bridge Adapter
DelrinEVA
GlassHigh Frequency Cord
Defibrillator
Slide for Cannula Tubing
Telescope
Wide Field Vitrectomy Lens
Cavity Clip

KratonPiston Syringe with Thumb Control Ring
Non-vented Luer Dispenser Tip Cap
Pediatric Tuohy Borst Adapter

Neoprene

Neoprene Rubber Tubing

None

Pass

Noryl

STERIS V-PRO Sterilization Tray

None

Pass

High Frequency Cord

Yes

Fail after 39th Cycle*

Nylon

Resectoscope Sheath
Resectoscope Obturator
Pediatric Tuohy Borst Adapter

Fading

Pass

None

17

Table 22. Material Compatibility (continued)
Materials

Instrument Evaluated

Cosmetic Change

Functionality

PEEK

Endoscope

None

Pass

PMMA

Contact

None

Pass

Polycarbonate

Reusable Nebulizer

None

Pass

Polyethylene

Piston Syringe with Thumb Control Ring

None

Pass

None

Pass

Defibrillator
Forceps
Polypropylene

Piston Syringe with Thumb Control Ring
Reusable Nebulizer
STERIS V-PRO Sterilization Tray

Polystyrene

Non-vented Luer Dispenser Tip Cap

None

Pass

Polyurethane

Flexible Endoscope

None

Pass

None

Pass

None

Pass

None

Pass

PTFE
PVC
Radel

Working Element
High Frequency Cord
Pediatric Tuohy Borst Adapter
Reusable Nebulizer
Adapter for STERIS SYSTEM 1
Resectoscope Working Element
High Frequency Cord

Silicone

Defibrillator

None
Pass

Forceps
Wide Field Vitrectomy Lens

Slight Discoloration

Reusable Nebulizer

None

Resectoscope Working Element

Slight discoloration

Microsurgical Scissors
Telescope
Resectoscope Sheath
Stainless SteelResectoscope Obturator
Forceps

None

Pass

Bone Chisel
Bridge Adapter
Probe Tip
STERIS V-PRO Sterilization Tray
Titanium

Bulldog Clamp

None

Pass

Ultem

Instrument Tray

None

Pass

* See Operator Manual for specific information on compatible materials. Some grades of Nylon, Delrin, and Radel devices may have limited life after repeatedsterilization.

Conclusion
Exposure to numerous cycles in the V-PRO maX Sterilizer does not significantly affect the appearance or functionality of mostmedical instruments.

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6

SafetyThe toxicology of hydrogen peroxide (H2O2) is well understood in the scientific literature. A thorough risk assessment of hydrogen
peroxide was completed in 2003 by the European Union. The by-products from hydrogen peroxide sterilization, formed upon decomposition, are water (H2O) and oxygen gas (O2).
2 H2O22 H2O + O2
These by-products do not present toxicity concerns to the user. Safeguards are in place to protect against potential exposure tohydrogen peroxide.

Liquid Peroxide
Under normal conditions of use, the Sterilizer operator is not exposed to the contents of the VAPROX HC Sterilant cup (59%hydrogen peroxide). The sterilant cup is sealed, and the user cannot access the sterilant without physically damaging the cup. A SDS isprovided to advise the user on safe handling practices.

Hydrogen Peroxide Vapors
The user places a sealed, vented sterilant cup into the Sterilizer. The Sterilizer automatically dispenses and injects hydrogen peroxide
into the low pressure chamber. At the end of each sterilization pulse, hydrogen peroxide vapor is removed from the chamber through acatalytic converter which converts the hydrogen peroxide into water and oxygen. To confirm this, the environment around the sterilizer was monitored under simulated use conditions for acceptable VHP levels during typical sterilization cycle conditions. The levels
were >20 times lower than the OSHA hydrogen peroxide gas Time Weighted Average (TWA) limit of 1 ppm. Testing with multiple
V-PRO Sterilizers verified that the sterilizers' PEL was less than the 1 ppm TWA limit and, in a 15-minute evaluation of the user’s
breathing zone, there was no detectable hydrogen peroxide.

Hydrogen Peroxide on Medical Instruments or Packaging
Biocompatibility testing was conducted for commonly used medical device materials after sterilization in the V-PRO maX Sterilizer
to verify effective removal of residuals. As part of the testing, cytotoxicity screening evaluations were conducted. Cytotoxicity is anextremely sensitive methodology that can identify a material as causing a positive cytotoxic response even though that material has anestablished history of safe clinical use. Therefore, the results obtained after processing in the V-PRO maX Sterilizer were comparedto those obtained using a similar technology that has been in clinical use for over fifteen years. In addition to cytotoxicity evaluations,ocular irritation, acute systemic toxicology, intracutaneous irritation and blood compatibility evaluations were performed. The resultsfrom these tests demonstrate that items processed in the V-PRO maX Sterilization System do not have their innate biocompatible
characteristics altered or compromised.
In accordance with ISO EN 10993-17 Biological Evaluation of Medical Devices- Part 17: Establishment of allowable limits forleachable substances, a risk analysis was conducted and safe levels of residual hydrogen peroxide were established. A risk assessment
completed by the European Commission (2003) was used as primary source document for this assessment. The V-PRO maX Sterilization System was shown to reduce the levels of residues on representative medical devices (12 medical devices including flexible
endoscopes, resectoscope and forceps) to well below the established residue limits (greater than 9 to 800 fold lower than the allowable
residue limit for internal tissue contact established in accordance with ISO 10993-17) proving that the V-PRO maX Sterilizer effectively eliminates toxic process residuals.

7

Conclusion

The V-PRO maX Low Temperature Sterilization System can be used to safely and effectively terminally sterilize properly prepared(cleaned, rinsed and dried) metal and nonmetal medical devices used in healthcare facilities.

19Document #10037127 Rev. D (M3635EN)©2017 STERIS Corporation
All Rights Reserved

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STERIS Corporation
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Mentor, OH 44060-1834 • USA
440-354-2600 • 800-548-4873
www.steris.com